The Tilt Test-Induced REsponse in Closed-loop Stimulation (TIRECS) Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Multicentre, prospective, double blinded, randomized study designed as an intrapatient comparison to evaluate the effects of the Biotronik Closed-loop Stimulation algorithm on prevalence and timing of haemodynamic variations and clinical prodromes induced by head-up tilt test in patients underwent pacemaker implantation for refractory cardioinhibitory vasovagal syncope.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Effect of Closed Loop Pacemaker Treatment on Recurrent Vasovagal Syncope

NCT00292825

Vasovagal Syncope

COMPLETED NA

Risk of Syncopal Relapses in Patients Treated With Permanent Pacing for Bradyarrhythmic Syncope

NCT04229589

Syncope

UNKNOWN

Optimizing Diagnostics Of Syncope Events Using Intelligent Telemetric Solutions.

NCT01265290

Cardiac Arrhythmia Cardiogenic Syncope

UNKNOWN NA

Guideline-based Pacing Therapy for Reflex Syncope

NCT01509534

Syncope

COMPLETED

ISSUE3: International Study on Syncope of Uncertain Etiology 3

NCT00359203

Syncope

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

A total of 30 patients with refractory cardioinhibitory vasovagal syncope receiving a Biotronik pacemaker with Closed-loop Stimulation (CLS) algorithm will be enrolled in the study. Two head-up tilt test (HUTT), one during DDD 60/min pacing with CLS algorith turned off (CLS-OFF) and the other during DDD-CLS pacing (CLS-ON), will be performed one week apart; patients will be randomly and blindly assigned to group A (n=15, first HUTT in CLS-ON mode) or B (n=15, first HUTT in CLS-OFF mode). During HUTT heart rate, blood pressure, and the incidence of clinical prodromes and syncope wil be recorded.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Syncope, Vasovagal, Neurally-Mediated

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CLS-ON first

Closed-loop Stimulation on first

Group Type ACTIVE_COMPARATOR

Closed-loop Stimulation on first

Intervention Type DEVICE

Closed-loop Stimulation algorithm is turned on in the device. The patient performs a head up tilt test. After a week Closed-loop Stimulation algorithm is turned off and the patient performs a second head up tilt test.

CLS-OFF first

Closed-loop Stimulation off first

Group Type ACTIVE_COMPARATOR

Closed-loop Stimulation off first

Intervention Type DEVICE

Closed-loop Stimulation algorithm is turned off in the device. The patient performs a head up tilt test. After a week Closed-loop Stimulation algorithm is turned on and the patient performs a second head up tilt test.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Closed-loop Stimulation on first

Closed-loop Stimulation algorithm is turned on in the device. The patient performs a head up tilt test. After a week Closed-loop Stimulation algorithm is turned off and the patient performs a second head up tilt test.

Intervention Type DEVICE

Closed-loop Stimulation off first

Closed-loop Stimulation algorithm is turned off in the device. The patient performs a head up tilt test. After a week Closed-loop Stimulation algorithm is turned on and the patient performs a second head up tilt test.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Refractory cardioinhibitory vasovagal syncope treated with permanent pacemaker;
* Pacemaker Biotronik with Closed-loop Stimulation algorithm
* Ability to perform a head up tilt test
* Completion of the 18th year of age